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Hormone Therapy

Leuprolide Oral Tablet - 120 mg - QD- Treatment A for Endometriosis

Phase 2
Waitlist Available
Research Sponsored by Enteris BioPharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment days: 1,8, 15, 22 and 29; post dosing day 14
Awards & highlights

Summary

This study is evaluating whether a drug can suppress estrogen levels in women.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment days: 1,8, 15, 22 and 29; post dosing day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment days: 1,8, 15, 22 and 29; post dosing day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adequacy of suppression of estradiol (E2) as assessed by the subject incidence of estradiol level below 20 pg/mL
Secondary outcome measures
(Pre-dose leuprolide level) Subject incidence of Leuprolide below detectable level
Composite Pelvic Signs and Symptoms (CPSS) scores
Follicle Stimulating Hormone (FSH) levels
+3 more

Side effects data

From 2019 Phase 4 trial • 107 Patients • NCT03035032
17%
Prostatic specific antigen increased
9%
Cough
8%
Back pain
8%
Hot flush
6%
Anaemia
6%
Upper respiratory tract infection
4%
Pneumonia
3%
Death
2%
Neuralgia
2%
Haemorrhage intracranial
2%
Arthralgia
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Syncope
1%
Dysuria
1%
Epistaxis
1%
Hyperglycaemia
1%
Deep vein thrombosis
1%
Fluid overload
1%
Dementia
1%
Dyspnoea
1%
Musculoskeletal chest pain
1%
Prostate cancer metastatic
1%
Muscular weakness
1%
Headache
1%
Pain in extremity
1%
Septic shock
1%
Viral upper respiratory tract infection
1%
Femur fracture
1%
Spinal compression fracture
1%
Weight decreased
1%
Cardiac failure congestive
1%
Abdominal wall haematoma
1%
Anal hypoaesthesia
1%
Incarcerated inguinal hernia
1%
Inguinal hernia
1%
Inguinal hernia, obstructive
1%
Pancreatitis
1%
Proctalgia
1%
Vomiting
1%
Multiple organ dysfunction syndrome
1%
Peripheral swelling
1%
Appendicitis
1%
Gastroenteritis
1%
Sepsis
1%
Spinal cord compression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Leuprolide Acetate 22.5 mg

Trial Design

5Treatment groups
Experimental Treatment
Group I: Treatment E:Leuprolide Oral Tablet (Ovarest), 40 mg BIDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 40 mg, administered twice daily (BID), 12 hours apart for up to 29 consecutive days with food-intake restrictions.
Group II: Treatment D: Leuprolide Oral Tablet, 60 mg BIDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 60 mg, administered twice daily (BID), 12 hours apart for up to 35 consecutive days with food-intake restrictions.
Group III: Treatment C: Leuprolide Oral Tablet, 60 mg QDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 60 mg, administered once daily (QD) for up to 29 consecutive days with food-intake restrictions.
Group IV: Treatment B: Leuprolide Oral Tablet, 80 mg QDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 80 mg (2 x 40 mg tablets), administered once daily (QD) for up to 35 consecutive days with food-intake restrictions.
Group V: Treatment A: Leuprolide Oral Tablet, 120 mg QDExperimental Treatment1 Intervention
Leuprolide Oral Tablet (Ovarest), 120 mg (2 x 60 mg tablets), administered once daily (QD), for up to 35 consecutive days with food-intake restrictions.

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
306 Previous Clinical Trials
101,067 Total Patients Enrolled
Enteris BioPharma Inc.Lead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
1 Trials studying Endometriosis
35 Patients Enrolled for Endometriosis
Syneos HealthOTHER
173 Previous Clinical Trials
68,133 Total Patients Enrolled
1 Trials studying Endometriosis
35 Patients Enrolled for Endometriosis
~5 spots leftby Jul 2025